TADALAFIL tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT)

Available from:

Proficient Rx LP

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tadalafil tablets are indicated for the treatment of erectile dysfunction (ED). If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil beyond 26 weeks is unknown [see Clinical Studies ( 14.3)] . Administration of tadalafil tablets to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies, tadalafil was shown to potentiate the hypotensive effect of nitrates [see Clinical Pharmacology ( 12.2)] . Tadalafil tablets are contraindicated in patients with a known serious hypersensitivity to tadalafil (tadalafil tablets or ADCIRCA ® ). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatit

Product summary:

Tadalafil tablets, USP 10 mg are available for oral administration as yellow coloured, almond shaped, biconvex, film coated tablets, debossed with “FJ3” on one side and plain on other side Bottles of 10 count (NDC 71205-502-10) Bottles of 15 count (NDC 71205-502-15) Bottles of 30 count (NDC 71205-502-30) Bottles of 60 count (NDC 71205-502-60) Bottles of 90 count (NDC 71205-502-90) Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TADALAFIL- TADALAFIL TABLET, FILM COATED
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TADALAFIL TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TADALAFIL
TABLETS.
TADALAFIL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the
treatment of:
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If tadalafil tablets are used with finasteride to initiate BPH
treatment, such use is recommended for up to
26 weeks ( 1.4).
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 2.5 mg, 5 mg, 10 mg, 20 mg ( 3).
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (≥2%) include headache, dyspepsia,
back pain, myalgia, nasal
congestion, flushing, and pain in limb ( 6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ACCORD HEALTHCARE INC.
AT 1-866-941-
7875 OR _WWW.ACCORDHEALTHCARE.US_ OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH
erectile dysfunction (ED) ( 1.1)
the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2)
ED and the signs and symptoms of BPH (ED/BPH) ( 1.3)
_Tadalafil tablets for use as needed:_
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ED: Starting dose: 10 mg as needed prior to sexual activity. Increase
to 20 mg or decrease to
5 mg based upon efficacy/tolerability. Improves erectile function
compared to placebo up to 36
hours post dose. Not to be taken more than once per day ( 2.1).
_Tadalafil tablets for once daily use:_
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ED: 2.5 mg taken once daily, without regard to timing of sexual
activity. May increase to 5 mg
based upon efficacy and tolerability ( 2.2).
BPH: 5 mg, taken at approximately the same time every day ( 2.3).
ED and BPH: 5 mg, taken at approximately the same time every day (
2.3, 2.4).
Tadalafil tablets may be taken without regard to food ( 2.5).
Administration of tadalafil tablets to patients using any form of
organic nitrate is contraindicated.
Tadalafil